EKTERLY FILM-COATED TABLETS 300 MG [SIN17392P]
Active ingredients: EKTERLY FILM-COATED TABLETS 300 MG
Last updated 24 April 2026
Product Info
EKTERLY FILM-COATED TABLETS 300 MG
[SIN17392P]
Product information
Active Ingredient and Strength | SEBETRALSTAT - 300 MG |
Dosage Form | TABLET, FILM COATED |
Manufacturer and Country | CATALENT NOTTINGHAM LIMITED - UNITED KINGDOM |
Registration Number | SIN17392P |
Licence Holder | PHARMA TO MARKET PTE. LTD. |
Forensic Classification | PRESCRIPTION ONLY MEDICINES |
Anatomical Therapeutic Chemical (ATC) code | B06AC08 |
Prescription-only Medicines with Exemptions for Supply without Prescription | NA |
Indication
4.1 Therapeutic indications
Ekterly is indicated for the treatment of hereditary angioedema (HAE) attacks in adult and adolescents aged 12 years and older.
Dosing
4.2 Posology and method of administration
Posology
The recommended dose of Ekterly is 300 mg administered at the earliest recognition of an attack. An additional dose may be taken if needed.
Special populations
Elderly population
No dose adjustment is required for patients above 65 years of age (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Renal impairment
No dose adjustment is required for patients with renal impairment.
Hepatic impairment
No dose adjustment of Ekterly is required for patients with mild or moderate hepatic impairment (Child-Pugh A or B). Use of Ekterly in patients with severe hepatic impairment (Child-Pugh C) is not recommended.
Paediatric population
The safety and efficacy of sebetralstat in children under 12 years of age have not been established.
No data are available.
Patients taking strong CYP3A4 inhibitors
In patients who are taking a strong CYP3A4 inhibitor a single dose of 300 mg is recommended when treating an HAE attack. Use of an additional dose is not recommended.
Patients taking strong or moderate CYP3A4 inducers
In patients who are taking strong or moderate CYP3A4 inducers a single dose of 900 mg (3 x 300 mg tablets) is recommended when treating an HAE attack.
Method of administration
For oral use. The film-coated tablets can be taken with or without food (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).
Contraindications
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.